Radiation to the prostate alone versus prostate and nearby lymph glands
Compares two radiation plans for men with high-risk localised prostate cancer.
Plain-language title generated from the registry record
Registry title: A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
Key facts
- Where
- Auckland, New ZealandSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with high risk prostate cancer that has not spread, who are planned for hormone therapy. It compares radiotherapy to the prostate alone with radiotherapy to the prostate and pelvic lymph nodes, each given in 5 visits.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- High risk prostate cancer that has not spread: Gleason 8-10, or stage T3a/b or T4, or PSA above 20ng/ml (above 10 ng/ml for men on 5-alpha reductase inhibitors). Cancer confirmed by biopsy. No lymph node or distant spread (N0M0).
- Earlier treatment
- Planned for 12-36 months of androgen deprivation therapy. No previous active treatment for prostate cancer. No chemotherapy within 6 weeks of the start of radiotherapy.
Main reasons for not taking part
- Cancer in the lymph nodes (N1) or spread elsewhere (M1)
- Previous pelvic radiotherapy, inflammatory bowel disease or significant lower urinary tract symptoms
- PSA above 50ng/ml (above 25ng/ml on 5-alpha reductase inhibitors) unless PET-CT confirms no spread
- Bilateral hip prostheses or other implants that would make pelvic node planning more difficult
- Life expectancy under 5 years
Read by machine on 9 November 2026.
Where in New Zealand
- Auckland HospitalAuckland, New ZealandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Cancer Research, United Kingdom
- Trial code
- NCT05613023
- Record updated
- 19 September 2024
- Original description
This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer.Read full original descriptionShow less
PACE-NODES. A Phase III Randomised Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
This study will compare the safety and efficacy of curative radiotherapy to the prostate and lymph glands given in 5 visits to that of prostate alone radiotherapy given in 5 visits, in men with high risk localised prostate cancer.
Inclusion: Aged ≥ 18 years at randomisation; Histopathological confirmation of prostate adenocarcinoma with Gleason/ISUP grade group scoring within twelve months of randomisation (unless otherwise discussed with the CI or co-Clinical Leads); Patients planned for 12-36 months androgen deprivation therapy; High risk localised prostate cancer as defined by; Gleason 8-10 (grade groups 4 and 5) and/or; Stage T3a/b or T4 and/or; PSA > 20ng/ml (or >10 ng/ml for patients on 5-alpha reductase inhibitors); Multi-parametric MRI of the pelvis- to include at least one functional MRI sequence in addition to T2W imaging within twelve months of randomisation; Radiological staging to exclude metastatic disease, prior to starting ADT, with one of the following: PSMA PET-CT, fluciclovine/choline PET-CT, whole-body MRI, bone scan, CT of chest, abdomen and pelvis (imaging method as per local practice/standard of care); WHO performance status 0-2; Ability of research subject to give written informed consent.
Exclusion: Previous active treatment for prostate cancer; Patients where SBRT is contraindicated: prior pelvic radiotherapy, inflammatory bowel disease, significant lower urinary tract symptoms N.B. where patient has repeated imaging showing bowel in close apposition to target volumes that would make pelvic radiotherapy highly unlikely to be deliverable should be excluded; Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts and would make pelvic node planning more difficult; Patients who have had chemotherapy within 6 weeks of the start of radiotherapy; N1 or M1 disease; PSA >50ng/ml (or >25ng/ml for patients on 5-alpha reductase inhibitors), unless PET-CT imaging has been performed to confirm N0M0 disease; Contraindications to fiducial marker insertion, where used- including clotting disorders, or patients at high risk when stopping anticoagulation or antiplatelet medications; Life expectancy < 5 years.